Label: GOODSENSE ANTACID FRUIT CHEWS- calcium carbonate tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 75981-012-32 - Packager: Geiss, Destin & Dunn
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 30, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR/PHARMACIST
- DO NOT USE
- WHEN USING
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive ingredients: Beeswax, carmine, carnauba wax, citric acid, corn starch, corn syrup, DL-alpha tocopherol, ethyl acetate, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 5 lake (tartrazine), FD&C yellow no. 6, FD&C yellow no. 6 aluminum lake, gum arabic, hydrogenated coconut oil, maltodextrin, medium chain triglycerides, methyl paraben, modified corn starch, natural and artificial flavors, phosphoric acid, pregelatinized corn starch, propyl paraben, propylene glycol, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, soybean oil, sucrose, and titanium dioxide.
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INGREDIENTS AND APPEARANCE
GOODSENSE ANTACID FRUIT CHEWS
calcium carbonate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75981-012 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE 750 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Product Characteristics Color orange (Orange, Pink, & Yellow) Score no score Shape ROUND Size 14mm Flavor ORANGE (Orange, Strawberry, & Lemon) Imprint Code FC Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75981-012-32 32 in 1 BOTTLE; Type 0: Not a Combination Product 06/30/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 06/30/2021 Labeler - Geiss, Destin & Dunn (076059836) Registrant - Bestco LLC (002149136) Establishment Name Address ID/FEI Business Operations Bestco LLC 002149136 manufacture(75981-012)